MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, EMBOLIZATION, VASCULAR

Model Number	APB-4-12-3D-SS
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No bends or kinks were found with the axium prime pushwire.The implant coil was found not attached to the pushwire.Under the m icroscope, the coin was located against the lumen stop, with the shield coil present and with the detach element extending out.The implant coil was found to have broken from the pushwire at the coil shell.The broken implant coil was found extending out from within both ends of the introducer sheath.The implant coil was found damaged and stretched with the polypropylene filament broken.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was confirmed as the axium prime implant coil was found stretched.In addition, the implant coil was found broken from the pushwire; however, the customer did not report the detachment of the implant coil at the time of the event.Possible contributing factors to ¿coil stretch¿ include navigation through severely tortuous anatomy, resistance during delivery, and difficulty, or repeated repositioning.There was not any resistance during the delivery of the axium prime coil in the catheter, the vessel tortuosity was ¿normal¿, and the physician did not reposition the coil.It is likely the removal of the implant coil from within the micro catheter caused the implant coil to stretch subsequently detachment of the implant coil.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that,during procedure, the implant coil was found to be stretched when it was withdrawn from the microcatheter.The implant coil was replaced and the procedure was completed successfully.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of an unruptured aneurysm measuring 4mm x 2mm located in the c4 segment of the left internal carotid artery (ica).The patient¿s vasculature was normal in tortuosity and the blood flow was normal.It was noted that the access vessel was the internal carotid artery with a size of 4mm.There was no friction during testing or delivery, the catheter was flushed as indicated per the ifu, and the coil was hydrated as indicated per the ifu.The physician did not attempt to reposition the coil.There are no images for review.Ancillary devices: synchro guidewire, echelon microcatheter, 6f long sheath.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8637022
• Report Number: 2029214-2019-00478
• Device Sequence Number: 11223885
• Product Code: KRD
• UDI-Device Identifier: 00847536008120
• UDI-Public: 00847536008120
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2021
• Device Model Number: APB-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: A714025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR